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Not Yet Recruiting NCT05762198

A Randomized Controlled Trial Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

Conditions: Prostate Cancer

Sex: Male
Ages: 50 Years – 80 Years
Phase: NA
Enrollment: 108
Sponsor: Chinese University of Hong Kong

Location: Hong Kong

Summary

This is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (REZUM) arm or transurethral resection of prostate (TURP) arm.

Eligibility Criteria

Inclusion Criteria:Men 50-80 yearsRefractory urinary retention related to benign prostatic hyperplasia (BPH)On urethral Foley's catheter before treatmentProstate size 30-80ml on ultrasoundExclusion Criteria:Prior prostate operationPast or current history of prostate cancerStrong suspicion of prostate cancer (e.g. Elevated PSA before urinary retention or abnormal prostate on DRE without workup for prostate cancer)Known Urethral stricture / Bladder stone / Hypocontractile bladderKnown neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke)Contraindicated to undergo TURP or REZUM (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05762198). StuddyBuddy aggregates publicly available trial information.